The cPass kit has the potential to detect Covid-19 neutralising antibodies without the use of live virus
GenScript has secured FDA EUA for use of cPass Covid-19 test in convalescent plasma screening. (Credit: Thor Deichmann from Pixabay)
The US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) has granted an emergency use authorisation (EUA) for use of GenScript USA’s cPass SARS-CoV-2 neutralisation antibody detection kit in convalescent plasma screening.
The cPass kit is claimed to be the first FDA authorised test, which specifically identifies Covid-19 neutralising antibodies without using live virus.
Neutralising antibodies hold the potential to restrict the virus to infect a cell and are widely known biomarkers of immunity.
Convalescent plasma from patients who have recovered from Covid-19 is expected to include antibodies that battle the virus. It is generally used as a transfusion treatment for patients hospitalised with Covid-19 to speed recovery.
GenScript’s cPass kit is said to detect the functionality and level of antibodies in convalescent plasma earlier to its use in treatment.
According to the company, the traditional method to measure neutralising antibodies in the patient samples needs the use of live cells. It requires multiple days and high safety level environment (BSL3) to generate results.
In contrast, the cPass kit uses pure proteins that can be conducted in most standard laboratories with short turnaround time (~1hr).
The cPass kit is also CE marked in Europe and secured approval from ANVISA in Brazil, Health Sciences Authorities in Singapore and Ministry of Health and Prevention in the UAE, in addition to the FDA EUA status.
GenScript Life Science Group’s new product management vice president David Martz said: “Since the cPass kit was authorized for emergency use by the FDA late last year, more than 300 organisations have adopted it to detect these critical antibodies.
“We are excited to expand the use of this assay for convalescent plasma screening and look forward to bringing it to health care facilities to help increase the effectiveness of convalescent plasma treatment, ultimately helping patients to recover more quickly from Covid-19.”